Director of Biomarker Discovery – Diagnostics- Cambridge
A fantastic opportunity has arisen for a Director of Biomarker Discovery to join a dynamic biotech company based in Cambridge. This organisation are leaders the development and application of novel diagnostics and therapeutics that will revolutionise the way we detect disease. After enjoying a period of significant growth they are now looking to further continue their development on an international level.
As the Director of Biomarker Discovery you will report directly into the VP of Discovery. This is a key commercial and strategic role and the company are looking for a forward thinking, innovative, make-it-happen Director of Biomarker Discovery.
*Reporting into the VP of Bio Discovery and working closely with the company’s senior management and leadership teams, delivering the biomarker discovery CRC study, and other programmes of activity as needed.
*Playing a key role in the leadership of the biomarker discovery team and reviewing, monitoring and being proactive in the development and performance deliverables of your team members
*Working across teams to ensure lab workflows are validated and scalable
*Ensuring all biomarker discovery and analytical validation studies at a standard suitable for regulatory agency scrutiny
*Provide relevant, accurate and timely information for management reporting and Board
*Understand and mitigate key elements of the company’s risk profile
*Construct and monitor reliable control systems
*Ensure that your team complies with all legal and regulatory requirements. Critical in business-ready audits and regulatory affairs
*Responsible for driving the quality initiative within the Biomarker discovery team, including recording non conformances, carry out route cause analysis, CAPA management and SOP development, aiming for continual improvement
*Ensure that record keeping meets the requirements of auditors and government agencies
*Report risk issues to the VP, CEO and the management team
*Maintain relations with external auditors and investigate their findings and recommendations
*Responsible for collation of information and presenting of Board collateral and oversight of the team’s project plans
To be considered for this opportunity you must be educated to PhD level, and you are an experienced leader who has operated extensively within the biomarker discovery and/diagnostics fields. You are competent in the field of biomarker discovery with extensive practical knowledge of lab practices, Quality Assurance and Control and US regulatory frameworks including the FDA. You will have experience of Analytical Validation of assays and taking new cutting-edge diagnostics through the regulatory approvals (US and European). It is essential that you have worked in ISO 13485 and ISO 15189 environments. On a technical level the ideal candidate will also have strong experience in next generation sequencing.
This is a fantastic opportunity to play a leading role in an entrepreneurially driven company and to drive forward the company’s strategic objectives. In return they are offering a competitive salary and benefits package. For further information on this superb opportunity please feel free to contact myself, Lauren Gripton of Paramount Recruitment, firstname.lastname@example.org
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Job Reference: Lg54767_1541759399
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Science R and D
Recruitment Consultant: Director of Biomarker Discovery – Cambridge